MRNA vaccine aims to prevent shingles in older adults
NCT ID NCT07400003
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new mRNA vaccine to prevent shingles (herpes zoster) in adults aged 40 and older. The vaccine uses mRNA technology, similar to some COVID-19 vaccines, and is freeze-dried for easier storage. Researchers will compare different doses against existing vaccines and a placebo to see which is safest and most effective at triggering immunity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lyophilized herpes zoster virus mRNA vaccine
- What this could lead to
- If successful, this could lead to a new, more effective shingles vaccine that is easier to store and transport.
- What could go wrong
- This is an early phase 1/2 trial, so safety and effectiveness are not yet proven. The vaccine may cause side effects or fail to generate a strong immune response.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 519 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Phase I: Age ≥ 40 years; Phase II: Age ≥ 50 years; * Participants are able to understand and voluntarily sign the informed consent form; * Able to provide legal identification; * Participants of childbearing potential and their sexual partners agree to voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 6 months after the last dose of the investigational vaccine, with no plans for sperm or egg donation; * Agree to comply with the visit schedule, sample collection, vaccination, and other trial procedures throughout the study period, and remain accessible at all times during the trial. Exclusion Criteria: * History of chickenpox or herpes zoster in adulthood; * History of chickenpox or herpes zoster vaccination (including administration of registered products or participation in clinical trials of chickenpox or herpes zoster vaccines); * Close contact with patients infected with chickenpox or herpes zoster within the past 30 days; * Clinically significant abnormalities in protocol-specified clinical laboratory tests prior to vaccination (applicable to Phase I clinical trials only): A. Hematological parameters: White blood cell count (WBC), hemoglobin (Hb), platelet count (Plt); B. Blood biochemical parameters: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), fasting blood glucose (Glu), creatinine (CR); C. Urinalysis parameter: Urine protein (PRO); D. Coagulation parameters: Prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Fib), international normalized ratio (INR); E. 12-lead electrocardiogram (ECG). * Poorly controlled chronic diseases or significant medical history, including but not limited to cardiovascular diseases (e.g., poorly controlled hypertension defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg for participants aged 40-59 years prior to enrollment, or systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg for participants aged ≥60 years), metabolic disorders (e.g., poorly controlled diabetes), hematological diseases, hepatic or renal diseases, digestive system diseases, respiratory system diseases, history of major organ transplantation, or malignancy within the past five years; * History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that increases the risk of myocarditis or pericarditis; * Autoimmune diseases, immunodeficiency diseases, or family history thereof (including but not limited to psoriasis, systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, acute disseminated encephalomyelitis, facial paralysis, hypersensitivity reactions, polymyalgia rheumatica, rheumatoid arthritis, Guillain-Barré syndrome, asplenia, functional asplenia, HIV infection); * Coagulation disorders (e.g., coagulation factor deficiencies, platelet abnormalities, or other coagulopathies); * Current or previous severe neurological disorders (epilepsy, convulsions, or seizures) or psychiatric illnesses, or family history of psychiatric disorders; * Acute illnesses or acute exacerbations of chronic diseases within the past 7 days, or known or suspected active infections; * Immunosuppressive therapy or other immunomodulatory treatments (prednisone ≥20 mg/day or equivalent for \>14 days), cytotoxic therapy within the past 6 months, or planned use during the trial; * Administration of immunoglobulins or other blood products within the past 3 months (use of hepatitis B immunoglobulin within the past 1 month), or planned use during the trial; * Participation in other clinical studies within the past 30 days or planned participation during this trial; * Vaccination with live-attenuated vaccines or nucleic acid vaccines within the past 28 days, or vaccination with subunit, inactivated, or other types of vaccines within the past 14 days; * Known allergy to vaccines or vaccine components, such as urticaria, dyspnea, or angioedema following vaccination; * Pregnancy, lactation, or positive urine pregnancy test in female participants; * Fever (axillary temperature ≥37.3°C) within 3 days prior to vaccination or use of antipyretics, analgesics, or antihistamines (e.g., acetaminophen, ibuprofen, loratadine, cetirizine, etc.) as reported during inquiry; * Physical examination deemed unsatisfactory on the day of planned vaccination; * Skin lesions, inflammation, ulcers, rashes, scars, or other conditions at the target injection site that may interfere with administration or local reaction assessment; * Any other factors deemed by the investigator to render the participant unsuitable for participation in the clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
RECRUITINGXinjiang, 831100, China
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Other studies related to the condition(s) this trial covers.
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